KarlaLuise
by GANTER Shoes GmbH EUDAMED
Active
Ref 209977-0101Model Diabetic Protective Footwear
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9009211GanterDiabeticTK | Date12 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
- Germany
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- Diabetic Protective Footwear, 209977-0101
- Primary DI / UDI-DI
- 09010805200438, 09010805200315, 09010805200391, 09010805200353, 09010805200421, 09010805200407, 09010805200414, 09010805200339, 09010805200346, 09010805200377, 09010805200384, 09010805200445, 09010805200322, 09010805200360
- Basic UDI-DI
- 9009211GanterDiabeticTK
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- AT-MF-000044022
Other devices from GANTER Shoes GmbH
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No